NEWTON, Mass.–(BUSINESS WIRE)–Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, announced today a large-scale study that will investigate the burdens of incontinence on women in low- and middle-income countries to support equitable access to treatment. The first-of-its-kind study will examine how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms. Study results will be available in late 2023 and will inform the development of new treatment options based on the Leva® Pelvic Health System, a digital health treatment for urinary incontinence (UI) with published studies supporting its effectiveness, including durable, long-term symptom relief.

“In addition to improving access to treatment, we hope to engage multiple stakeholders within the private and public healthcare sector, academics, women’s networks, government, nongovernmental organizations and employers—to join us in supporting health equity and access to those most in need.”

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“When it comes to incontinence, there is a need to generate community awareness that it is treatable and sensitization and training of health workers to increase screening, deliver conservative and surgical treatment, and provide adequate follow-up,” says Mohan Chandra Regmi, MBBS, MD, Professor of Obstetrics and Gynecology, Director of the Foundation for International Urogynecological Assistance Fellowship Program in Nepal, and Chief Policy Advisor for the Government of Nepal. “The scope is simply huge.”

Approximately one-third of women in low- and middle-income countries experience at least one pelvic floor disorder, such as urinary or fecal incontinence (FI). Pelvic floor muscle training (PFMT) is globally accepted as first-line treatment for bladder and bowel leakage. Beginning in Nigeria and Kenya, the study will gather feedback from women living with incontinence, their family members, and clinicians to gain perspective on the impact of incontinence on women’s daily lives, symptom management strategies and how they access treatment through local healthcare systems. Axena Health will use these data to develop a treatment with Leva technology to support access to effective treatment for incontinence that is culturally acceptable and available within existing healthcare pathways. A second phase of the work will include formative and implementation research and is expected to include additional countries in Africa and South Asia.

“Urinary incontinence is a global health problem,” said Jessica McKinney, DScPT, MS, co-author of ‘Implementing Physical Rehabilitation Services into Comprehensive Fistula and Maternity Care: A Training Guide for Health Workers’, and Axena Health’s VP of Clinical Affairs and Global Health. “The physical, psychosocial, and economic burdens for women are significant and have been well documented primarily in high income countries. There is evidence in all settings that women’s livelihoods may be negatively impacted, and they may experience limited participation in family and community life. It is also true that UI is universally undertreated, and many women live with the health condition for the rest of their lives. Our intention with this study is to better understand and share women’s lived experiences with incontinence and direct actionable changes in awareness and treatment.”

The World Health Organization identifies urinary incontinence as a maternal morbidity and as a health priority for aging women, which includes a “strong recommendation” for PFMT. Data from the U.S. indicates that as few as 25 percent of women with a pelvic floor disorder perform PFMT despite a clinician’s direction. Of those who perform PFMT, fewer than 25 percent perform exercises adequately.

Currently available only in the U.S., the Leva System is a prescription, at-home medical device that guides a woman through first-line treatment for both UI and FI. The Leva System enables supervised PFMT in a manner that’s scalable, allowing clinicians to deliver effective, first-line treatment for incontinence to women. Study findings will inform a solution for use in low- and middle-income countries using Leva’s technology.

“We believe this is the first large, multi-faceted research study focused on how to deliver first line, non-surgical, drug-free treatment for incontinence aligned with the United Nations’ Sustainable Development Goals: specifically, ‘No Poverty,’ (goal one); ‘Good Health and Well-Being’ (goal three), ‘Gender Equality,’ (goal five) and ‘Reduced Inequalities,’ (goal ten). The burden of incontinence is gendered, and the costs borne by individuals and societies is multifactorial,” said Laura Keyser, DPT, MPH, co-author of the aforementioned Training Guide, and Director of Clinical Strategy and Global Health at Axena Health. “In addition to improving access to treatment, we hope to engage multiple stakeholders within the private and public healthcare sector, academics, women’s networks, government, nongovernmental organizations and employers—to join us in supporting health equity and access to those most in need.”

Strong clinical data support the efficacy of the Leva System, including two studies published in Obstetrics and Gynecology (The Green Journal). The first publication, an eight-week randomized controlled superiority trial (RCT) showed that the Leva System significantly improved symptoms of UI in women compared to PFMT (commonly referred to as Kegel exercises) alone. The second Green Journal publication, a one-year longitudinal follow up from the RCT, showed that women who used the Leva System for just eight weeks achieved long-term symptom relief that was durable. Shortly after the publication of that one-year durability data, Cigna Healthcare issued a positive medical policy coverage decision for the Leva System.

“Female incontinence is a significant unmet health need for millions of women worldwide, and we believe we’re uniquely able to help,” said Eileen Maus, CEO of Axena Health. “We’re grateful to our funding partner, AXA IM Alts, which is committed to providing innovative solutions to global health challenges and supports our goal to provide a Leva solution that is commercially available and broadly accessible to women and their clinicians in low- and middle-income countries. Our hope is that this work will help strengthen health systems and build greater capacity for women’s healthcare with key partners in lower-resourced settings in and outside of the U.S.”

The study will be conducted in collaboration with ThinkPlace, a global Design, Strategy & Innovation firm operating in over 10 countries. ThinkPlace works with leaders and organizations to tackle some of the world’s most pressing issues and has previously worked with renowned global organizations like the John Hopkins University, the Bill and Melinda Gates Foundation, Ministry of Health (Singapore), JnJ, BOSCH, UNICEF, and GAVI, among others.

About the Leva® Pelvic Health System

The Leva® Pelvic Health System is a prescription digital therapeutic (PDT) available in the United States that offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System is the first femtech product included in the Digital Therapeutics Alliance product library and has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG).

About Axena Health

Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health’s technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com and follow Axena Health on LinkedIn.

Important Indication and Other Information for the Leva® Pelvic Health System

The Leva® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.

At this time, the Leva® Pelvic Health System is only available in the United States.